166 Application of Quality By Design in Drug Product Process Development I

Monday, November 17, 2014: 3:15 PM
202 (Hilton Atlanta)
The importance of Quality-by-Design (QbD) for product process development has become increasingly apparent in the pharmaceutical industry, as this methodology promotes scientific and risk-based understanding during drug product development and scale-up. QbD approaches enable better product robustness and improved process control, the latter providing the potential to facilitate transition from batch to continuous manufacture. We invite submissions that demonstrate the application of QbD principles during process development of a drug product, especially when applied across multiple unit operations or to streamline drug product manufacture.

Pharmaceutical Discovery, Development and Manufacturing Forum

Jasmine M. Rowe
Email: jasmine.rowe@bms.com

True Rogers
Email: TLRogers@Dow.com

3:40 PM
(166b) Residence Time Distribution Measurement Via Video Analysis for Design of Experiment Characterization of Melt Extrusion
Patrick R. Wahl, Gudrun Hörl, Daniel Kaiser, Stephan Sacher, Johannes G. Khinast and Otto Scheibelhofer

4:30 PM
(166d) Behaviour of HPMC and Microcrystalline Cellulose during a Roller Compaction Process
Graham O'Mahony, Mary Ellen Crowley, Rakesh Dontireddy, Michael McAuliffe and Abina Crean

4:55 PM
(166e) Impact of Material and Source Variability on the Performance of Roller-Compacted Formulation and Critical Drug Product Attributes
Junshu Zhao, Otilia Koo, Yongmei Wu, Tejas Shah, Sandeep Rana, Dinesh Morkhade, Hubert Alby, Vishwas Nesarikar, Kevin Macias, Ruiling Hartley and Arturo Marin